Pleural Dynamics Gets FDA Clearance for its Automatic Continuous Effusion Shunt

It's fully implantable and powered by normal breathing.

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Pleural Dynamics

Pleural Dynamics, a medical device company that is building solutions for chronic, recurrent fluid collections in the body, today announced that the Company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. Pleural Dynamics provides a fully implantable automatic effusion shunt that is powered by normal breathing and is designed for continuous symptom relief, and does not require an extended hospital stay, a catheter external to the chest, or expensive drainage canisters.

The current standard of care, pleurodesis, is often painful and relies on an extended hospital stay, and while an alternate approach—indwelling pleural catheters—exists, it still requires that the patient have a portion of the tube external to the chest that requires frequent drainage into external canisters to relieve symptoms. Pleural Dynamics’ patented ACESâ„¢ System addresses these shortcomings1 with its’ one-piece, fully implanted system that can be placed during a short hospital stay. This technology is designed to use normal breathing motion to automatically pump pleural effusion fluid out of the chest to the abdomen for reabsorption by the body eliminating the need for an external catheter and frequent drainage, providing ongoing symptom relief.

With this FDA 510(k) clearance, Pleural Dynamics will begin real-world clinical use of the ACES™ System with select hospitals and health systems. Pleural Dynamics’ latest technology will play a vital role in improving the lives of patients with intractable pleural effusion.

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